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OPTIRAY® Ioversol Injection

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OPTIRAY® Ioversol Injection PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION OPTIRAY® Ioversol Injection OPTIRAY® 240 Ioversol Injection 51% w/v, 240 mgI/mL OPTIRAY® 300 Ioversol Injection 64% w/v, 300 mgI/mL OPTIRAY® 320 Ioversol Injection 68% w/v, 320 mgI/mL OPTIRAY® 350 Ioversol Injection 74% w/v, 350 mgI/mL Nonionic Iodinated Radiographic Contrast Medium Liebel-Flarsheim Canada Inc. 7500 Trans-Canada Highway Date of Revision: Pointe-Claire, QC, H9R 5H8 November 1, 2017 CANADA Submission Control No: 203281 Page 1 of 55 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ..................................................................................................13 DRUG INTERACTIONS ..................................................................................................19 DOSAGE AND ADMINISTRATION ..............................................................................19 OVERDOSAGE ................................................................................................................33 ACTION AND CLINICAL PHARMACOLOGY ............................................................33 STORAGE AND STABILITY ..........................................................................................36 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................36 PART II: SCIENTIFIC INFORMATION ...............................................................................39 PHARMACEUTICAL INFORMATION ..........................................................................39 DETAILED PHARMACOLOGY .....................................................................................40 TOXICOLOGY .................................................................................................................44 REFERENCES ..................................................................................................................50 PART III: PATIENT MEDICATION INFORMATION ........................................................52 Page 2 of 55 OPTIRAY® Ioversol Injection PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Dosage Form / Clinically Relevant Non-medicinal Administration Strength Ingredients Intravascular Solution for injection, Edetate Calcium Disodium USP, injection or 240 mgI/mL, 300 Hydrochloric Acid NF, Sodium Hydroxide subarachnoidal mgI/mL, 320 mgI/mL, NF, Tromethamine HCl, Tromethamine USP. and 350 mgI/mL For a complete listing see Dosage Forms, Composition and Packaging section. INDICATIONS AND CLINICAL USE Adults Optiray 350 administered intravascularly is recommended in adults for coronary arteriography and ventriculography, peripheral and visceral arteriography, intravenous contrast enhancement in computed tomography of the head and body, excretory urography, intravenous digital subtraction angiography and venography. Optiray 320 administered intravascularly is recommended for angiography throughout the cardiovascular system in adults. The uses include cerebral, coronary, peripheral, visceral and renal arteriography, aortography and left ventriculography. Optiray 320 is also recommended for contrast enhanced computed tomographic imaging of the head and body and in excretory urography. Optiray 300 administered intravascularly is recommended for use in adults for cerebral angiography, aortography, peripheral and visceral arteriography, intravenous contrast enhancement of computed tomography of the brain and body, excretory urography, intravenous digital subtraction angiography and venography. Optiray 240 administered intravascularly is recommended for use in adults for cerebral angiography,venography, excretory urography as was contrast enhanced Page 3 of 55 computed tomographic imaging of the head and body. Optiray 240 is indicated for subarachnoid administration in adults for lumbar, thoracic, and cervical myelography. Pediatric Optiray 350 administered intravascularly is indicated in children for angiocardiography. Optiray 320 administered intravascularly is recommended in children one year of age or over for angiocardiography, contrast enhanced computed tomography of the head and body and for excretory urography. Optiray 300 administered intravascularly is recommended in children one year of age or over for intravenous excretory urography and intra-arterial digital subtraction angiography. CONTRAINDICATIONS Optiray is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph. Optiray should not be administered to patients with clinically significant impairment of both hepatic and renal function. WARNINGS AND PRECAUTIONS WARNINGS USE THE RECOMMENDED OPTIRAY CONCENTRATION FOR THE PARTICULAR PROCEDURE TO BE UNDERTAKEN. A. General Serious or fatal reactions have been associated with the administration of all iodine containing radiopaque media, including Optiray. It is of utmost importance that a course of action be carefully planned in advance for immediate treatment of serious reactions, and that adequate facilities and appropriate personnel be readily available in case a severe reaction should occur. A previous reaction to a contrast medium of different chemical structure or a history of iodine sensitivity is not an absolute contraindication to the use of Optiray. However, extreme caution should be exercised in injecting these patients and prophylactic therapy Page 4 of 55 (as with corticosteroids for example) should be considered (see PRECAUTIONS, General). There must be a clear indication for performing procedures involving the administration of contrast agents in all patients. Patients with a history of allergy, bronchial asthma or other allergic manifestations, combined renal and hepatic disease, the elderly, debilitated or severely ill patients, those with homocystinuria, endotoxemia, elevated body temperature, severe hypertension or congestive heart failure, other cardiovascular disease, hyperthyroidism and recent renal transplant recipients, as well as patients sensitive to iodine, present an additional risk and call for careful evaluation of the risks involved against the benefits expected. Severe, life-threatening, systemic hypersensitivity reactions such as drug rash with eosinophilia and systemic symptoms have been reported in patients administered Optiray. Early or late manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Patients with a serum creatinine level above 3 mg/dL should not undergo excretory urography or other radiological procedures unless the benefits clearly outweigh the risks incurred. In patients with advanced renal disease, iodinated contrast media should be used with caution and only when the examination is essential since excretion of the medium is impaired. Use of Optiray is not recommended in patients with anuria or severe oliguria. Administration of radiopaque materials to patients known or suspected to have pheochromocytoma should be performed with extreme caution if, in the opinion of the physician, the possible benefits of such procedures outweigh the considered risks. The amount of radiopaque medium injected should be kept to an absolute minimum. The blood pressure should be assessed throughout the procedure and measures for treatment of a hypertensive crisis should be available. General anaesthesia may be indicated in some procedures; however, one should be aware of possible increased incidence of adverse reactions in such circumstances. Thyroid dysfunction Page 5 of 55 Optiray, like all other iodinated contrast media, may induce changes in thyroid function in some patients. Transient hyperthyroidism or hypothyroidism has been reported following iodinated contrast media administration to adult and pediatric patients. Decreased levels of thyroxine (T4) and triiodothyronine (T3) and increased level of TSH were reported after exposure to ICM in infants, especially preterm infants, which remained for up to a few weeks or even more than a month (see ADVERSE REACTIONS). Some patients were treated for hypothyroidism (see PRECAUTIONS – Pediatric Use- Infants). B. Vascular Use Intravascularly administered iodine-containing contrast media are potentially hazardous. Non-ionic iodinated contrast media, including Optiray, inhibit blood coagulation less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes, catheters or tubes containing non-ionic contrast media. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both non-ionic and ionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Numerous factors, including length of procedure,
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